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Stroke | Cerebrovascular Accident

Cells 4health

Information for patients

Health People

Stroke treatment with autologous stem cells from your own bone marrow.


Stroke | Cerebrovascular Accident

Cells 4health

Cerebrovascular Accident (CVA) A cerebrovascular accident is also known as a stroke. A stroke is a life-threatening event in which part of the brain is deprived of adequate oxygen. Strokes are dangerous (with 160,000 deaths a year in the US; the third leading cause of death). In the US, 700,000 people suffer a stroke each year; of those, 500,000 are first time strokes and 200,000 are recurrent. There are two kinds of strokes: - Ischemic strokes occur when the blood supply to the brain is interrupted, usually by a blood clot originating from the carotid arteries. These arteries feed the head and brain with oxygen-rich blood. The cause is usually atherosclerotic plaques in one of the arteries. - Hemorrhagic strokes occur when there is bleeding into or around the brain.

Common stroke consequences: The consequences from a stroke are often very severe; creating a burden for patients and those around them. - Paralysis and loss of feeling, most often in opposite body parts - Loss of vision - Speaking problems

Treatment Depending on the stroke's cause and its subsequent impact, there are different treatment options available. Stroke caused by a blood clot (ischemic stroke) is treated acutely with different kinds of medications, whereas stroke caused by a bleeding in the vessels (hemorrhagic stroke) is treated surgically. Besides these kinds of treatments, stem cell therapy can be used to minimize the chronic consequences of stroke.

- Aphasia (inability to communicate) - Reasoning and memory disturbances - Incontinence - Changes in character and emotions

The risk of stroke increases with age. Other reasons are high blood pressure, a brain injury and carotid artery dissection. Men are more likely to suffer a stroke; women are more likely to die from one.

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Stroke | Cerebrovascular Accident

Cells 4health

About Stem Cells The discovery of the stem cell has lead to a revolution in modern medicine. Stem cells are in fact, the “smart cells� of our bodies. These cells migrate to injured areas within the body and transform themselves into new tissue cells that replace the damaged ones. The body repairs itself by continuously producing new cells and tissues in this manner. Stem cells have the capacity to multiply and to renew themselves almost indefinitely. This contrasts with nerve cells, muscle cells and blood cells, which cannot multiply themselves and have limited life spans. Stem cells can also develop into specialized cells.

Stem cells from the bone marrow can develop into cardiac muscle, as well as liver, brain, nerve, fat and skin tissue. Examples of bone marrow-derived stem cell development are illustrated below

Liver

Adult Stem Cell

Skeletal muscle

The entire procedure consists of the following phases: eligibility, stem cell collection and processing, stem cell treatment, and follow-up. Objectives The goal of this treatment is to repair damaged tissue or to reactivate existing cells, thus recovering as much as possible, functions lost as a result of the stroke.

Bone marrow Blood cell Epithelial cell Cardiac muscle Neuron

Specialized Cell (e.g., neuron)

The Cells4health Stroke Treatment

Brain

Stem Cell

Stem Cell e.g., hematopoietic stem cell

In stroke patients, these stem cells can grow into nerve tissue, new blood vessels that improve circulation, or produce stimulants that activate non-active brain stem cells.

Type of treatment The Stroke procedure employs autologous adult stem cells. These cells are collected from your own bone marrow. A few days prior to treatment, the stem cells will be isolated from bone marrow taken from your hip (iliac crest).

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Stroke | Cerebrovascular Accident

Cells 4health

Eligibility phase

These pictures show the Bone Marrow Collection Procedure

If you meet the following conditions, you are eligible for treatment: - Stroke diagnosis based on your medical history, imaging material such as MRT or CT scan, radiology and a neurological report. - The Cells4health medical team approves you for treatment.

Bone Marrow Collection Procedure

- Your bone marrow contains a sufficient quantity of viable stem cells. This is assessed during the processing phase.

Preparation

Application of local anesthetic

Needle insertion into the hip bone (iliac crest)

Sample collection

Stem Cell Collection and Processing Prior to scheduling bone marrow collection, you will be asked to fill out the patient consent form. This form grants explicit written permission for bone marrow collection.

Disinfection of the collection site

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You must discontinue using any blood diluting medications at least 10 days before your collection date. You should consult your physician before discontinuing the use of blood diluting drugs. When we greet you on collection day, we'll have everythingprepared to begin collection and make it comfortable for you. Your physician will collect approximately 150 - 200 ml of bone marrow from your hip bone. Stem cell collection is performed as an out-patient procedure under local anesthesia in sterile conditions. It is comparable in pain to a dentist visit. During the collection, you will barely feel the needle insertion into your hip bone. Afterwards, the collection site might look like a "blue spot" and be a bit painful for 3 - 4 days. Normally, there are no other side-effects. Theoretically, there is a small risk of infection. We minimize this risk by working in a sterile environment. Within 48 hours, the stem cell samples are processed and quality tested by a highly specialized laboratory in in totally sterile, clean room conditions. Since they are in sterile tubes and never come into contact with the air, these samples cannot be contaminated.

Stroke | Cerebrovascular Accident

Bone marrow processing and quality testing consists of: - Stem cell isolation - stem cells are separated from the red blood cells and blood plasma. - Stem cell counting - Stem cell vitality measurement Stem cell processing results are documented in an analysis report. The result is positive if: - There are more than two million (2,000,000) CD34+ stem cells present. - The CD34+ stem cells have a vitality greater than 80% Positive isolated stem cell samples are stored in sterile tubes at minus 196oC in liquid nitrogen. Stem Cell Implantation Your high-quality stem cell sample can be implanted two ways: intrathecal injection (into spinal canal) and direct surgery (into the brain). Each method has distinct advantages and disadvantages.

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Stroke | Cerebrovascular Accident

Cells 4health

1. Intrathecal Injection

Treatment advantages:

and CT images enable the surgeon to precisely administer the stem cells into the damaged area. This procedure usually takes less than one hour.

Under a local anesthetic, your stem cells (in a volume of 4ml) will be injected directly into the cerebrospinal fluid via lumbar puncture. Since the cerebrospinal fluid circulates, stem cells are transported directly to the damaged tissue in the brain or the spinal cord. The entire procedure usually takes about 30 minutes. Immediately after treatment, you will spend about three or four hours laying in bed in our recovery room for observation. As with any minimally invasive intervention, intrathecal stem cell implantation carries a very small risk of infection. We minimize this risk by working in a sterile environment and by prescribing prophylactic antibiotics to you. If there are no complications, you can return home or to your hotel.

- Simple - Out patient - Less invasive than surgery - Lower cost than surgery

Immediately after the procedure, nurses will closely monitor you in the recovery room. Normally, you will be discharged after two or three days. Within a few weeks the wound will be almost invisible.

Treatment disadvantages:

Possible Adverse Events from the treatment

- Less precise application

- Reaction to anesthetic: nausea and headache - Infection - risk minimized by prescribing prophylactic antibiotics to each patient - Brain damage/bleeding - Wound healing problems - Epileptic attack

Possible Adverse Events from the treatment

2. Direct surgery

After the procedure, you might experience the following adverse events. These events can be intense but usually subside within two or three days. - Nausea - Headache - Backache and/or Leg pain

The highest precision targeting of stem cells is achieved with direct surgery. Stem cells are injected directly into the affected region in the brain. An experienced neurosurgeon will make a small hole in the skull. A catheter, guided by our neuronavigation system, is then inserted into the infarcted area. MRI

Follow-up Once you have returned home, a member of our medical team will regularly monitor your progress via telephone and email. For your convenience, a telephone 'hotline' is always at your disposal.

Treatment advantages - Highly precise application increases success rate Treatment disadvantages - More invasive than intrathecal procedure - Hospital stay is required - More expensive then intrathecal procedure 5


Stroke | Cerebrovascular Accident

Cells 4health

General

Note:

No additional charges will be incurred unless you are required to extend your stay at the medical center as a result of complications. Costs do not include additional stem cell treatments. If another treatment is necessary, we will discuss potential options with you. You will receive an invoice one week prior to treatment. This invoice must be paid in-full before treatment can begin.

If your bone marrow sample is negative or the stem cells cannot be administered due to unforeseen medical circumstances, you will only be required to pay charges incurred to that point. In the case of a negative bone marrow sample, it might be possible to schedule another bone marrow collection.

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